Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

Sharma, S., Babiker, A. G., Emery, S., Gordin, F. M., Lundgren, J. D., Neaton, J. N., Bakowska, E., Schechter, M., Wiselka, M. J. and Wolff, M. J. (2015) Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Medicine, 16 S1: 30-36. doi:10.1111/hiv.12231


Author Sharma, S.
Babiker, A. G.
Emery, S.
Gordin, F. M.
Lundgren, J. D.
Neaton, J. N.
Bakowska, E.
Schechter, M.
Wiselka, M. J.
Wolff, M. J.
Title Demographic and HIV-specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Journal name HIV Medicine   Check publisher's open access policy
ISSN 1468-1293
1464-2662
Publication date 2015-04-01
Year available 2015
Sub-type Article (original research)
DOI 10.1111/hiv.12231
Open Access Status Not yet assessed
Volume 16
Issue S1
Start page 30
End page 36
Total pages 7
Place of publication Chichester, West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Language eng
Formatted abstract
Objectives
The risks and benefits of initiating antiretroviral treatment (ART) at high CD4 cell counts have not been reliably quantified. The Strategic Timing of AntiRetroviral Treatment (START) study is a randomized international clinical trial that compares immediate with deferred initiation of ART for HIV-positive individuals with CD4 cell counts above 500 cells/μL. We describe the demographics, HIV-specific characteristics and medical history of this cohort.

Methods
Data collected at baseline include demographics, HIV-specific laboratory values, prior medical diagnoses and concomitant medications. Baseline characteristics were compared by geographical region, gender and age.

Results
START enrolled 4685 HIV-positive participants from 215 sites in 35 countries. The median age is 36 years [interquartile range (IQR) 29–44 years], 27% are female, and 45% self-identify as white, 30% as black, 14% as Latino/Hispanic, 8% as Asian and 3% as other. The route of HIV acquisition is reported as men who have sex with men in 55% of participants, heterosexual sex in 38%, injecting drug use in 1% and other/unknown in 5%. Median time since HIV diagnosis is 1.0 year (IQR 0.4–3.0 years) and the median CD4 cell count and HIV RNA values at study entry are 651 cells/μL (IQR 584–765 cells/μL) and 12 754 HIV RNA copies/mL (IQR 3014–43 607 copies/mL), respectively.

Conclusions
START has enrolled a diverse group of ART-naïve individuals with high CD4 cell counts who are comparable to the HIV-positive population from the regions in which they were enrolled. The information collected with this robust study design will provide a database with which to evaluate the risks and benefits of early ART use for many important outcomes.
Keyword Clinical trial
HIV
START trial
When to start antiretroviral therapy
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: Faculty of Medicine
 
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